Non Absorbable Surgical Nylon Suture
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Non absorbable Surgical Nylon Suture EUDAMED
- Device Name
- Non absorbable Surgical Nylon Suture EUDAMED
- Model / Reference
- 2/0 45cm Reverse cutting 3/8 26mm EUDAMED- EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06926973930554 EUDAMED
- Basic UDI-DI
- B-06926973930554 EUDAMED
- 510(k) Number
- K212603 FDA 510(k)
- FDA Product Code
- GAR FDA 510(k)
- EMDN Code
- H010201010101,H010201010102 EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.5020 FDA 510(k)
- Regulation Number
- 878.5020 FDA 510(k)
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The Non-Absorbable Surgical Nylon Suture is a synthetic, non-absorbable suture composed of polyamide. It is classified as a nonabsorbable suture under FDA nomenclature (878.5020), designed for use in general and plastic surgery procedures to approximate tissues and maintain wound closure over extended periods.
This suture is supplied in sterile, single-use packaging and is intended for use in surgical settings. It is available in multiple sizes and reference codes, as listed in the FDA database, and adheres to Medical Device Directive (MDD) and FDA 510(k) regulatory standards. The device is classified as Class II under FDA regulations and has been determined substantially equivalent through the traditional 510(k) clearance process.
Frequently asked questions
What types of surgical procedures is this nylon suture commonly used for according to its regulatory classification?
This non-absorbable surgical nylon suture is classified under FDA nomenclature (878.5020) and its regulatory submissions indicate it is intended for use in general and plastic surgery procedures. It is designed to approximate tissues and maintain wound closure over extended periods, making it suitable for applications requiring long-term support, such as skin closure, ligament repair, or soft tissue approximation.
Is this suture available in multiple sizes, and how would I identify the specific reference codes for different models?
Yes, this suture is supplied in multiple sizes, as evidenced by the extensive list of FDA registration numbers (e.g., 3038718579, 1221051, etc.) and product codes (GAR) in the regulatory database. These numbers correspond to distinct suture sizes, coatings, or packaging variants. For precise identification, refer to the manufacturer’s catalog or the FDA’s OpenFDA database, where these reference codes are cross-referenced with specifications like diameter, length, or coating type.
How is this suture packaged, and what should I know about its sterility and single-use status?
The suture is supplied in sterile, single-use packaging, as explicitly stated in the device description. This ensures contamination-free use in surgical settings and prevents reuse, which could compromise patient safety. The sterile barrier is designed to maintain integrity until the first use, after which it should be discarded.
What regulatory pathways has this device followed, and how does that affect its availability or approval status?
This suture has undergone FDA 510(k) clearance (traditional pathway) and complies with the Medical Device Directive (MDD) in Europe. It was determined substantially equivalent to a predicate device through the FDA’s review process, confirming its safety and effectiveness for the intended uses in general and plastic surgery. While these pathways indicate regulatory compliance, they do not imply current market availability—purchasers should verify distribution through authorized channels.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K212603 | Class II | Active |
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Manufacturer
- Manufacturer
- Shandong Haidike Medical Product Co., Ltd.
Sources (2)
- FDA 510(k) K212603 24 fields · synced Oct 6, 2026
- EUDAMED 815a3c6d-cc18-4286-a3c8-04725f3433d1 61 fields · synced Jul 29, 2026